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Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients (CIV)

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ClinicalTrials.gov Identifier: NCT01786161
Recruitment Status : Terminated (slow recruitment)
First Posted : February 7, 2013
Results First Posted : May 5, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hsin Jung Lin, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Interventions Drug: Vancomycin continuous infusion
Drug: Vancomycin intermittent dosing interval
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vancomycin With Continuous Infusion Vancomycin With Intermittent Dose Interval
Hide Arm/Group Description

continuous 24 hours intravenous infusion

Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion

infusion rate 1000mg/hr

Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr

Period Title: Overall Study
Started 22 22
Completed 22 22
Not Completed 0 0
Arm/Group Title Vancomycin Continous Infusion Intermittent Infusion Total
Hide Arm/Group Description Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion infusion rate 1000mg/hr

infusion rate 1000mg/hr

Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr

Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
60  (14.1) 53.7  (13.5) 56.8  (14.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
6
  27.3%
10
  45.5%
16
  36.4%
Male
16
  72.7%
12
  54.5%
28
  63.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22
 100.0%
22
 100.0%
44
 100.0%
1.Primary Outcome
Title Number of Participants Who Achieved the Target Vancomycin Concentration
Hide Description The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin With Continuous Infusion Vancomycin With Intermittent Dose Interval
Hide Arm/Group Description:

continuous 24 hours intravenous infusion

Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion

infusion rate 1000mg/hr

Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr

Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
20
  90.9%
5
  22.7%
2.Secondary Outcome
Title Time Required to Reach the Therapeutic Levels
Hide Description The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Time Frame as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin Continous Infusion Intermittent Infusion
Hide Arm/Group Description:

continuous 24 hours intravenous infusion

Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion

infusion rate 1000mg/hr

Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: hours
26.1  (7) 54.1  (25.8)
3.Secondary Outcome
Title Vancomycin Concentration at 24 Hours
Hide Description The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin Continous Infusion Intermittent Infusion
Hide Arm/Group Description:

continuous 24 hours intravenous infusion

Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion

infusion rate 1000mg/hr

Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mcg/mL
19.9  (3.7) 14.2  (6.6)
Time Frame Adverse event data were collected while subjects are receiving vancomycin therapy.
Adverse Event Reporting Description Nephrotoxicity was defined as an increase in serum creatinine (SCr) by 0.5 mg/dL or at least a 50% increase from baseline over 2 consecutive SCr values.
 
Arm/Group Title Vancomycin Continous Infusion Intermittent Infusion
Hide Arm/Group Description

continuous 24 hours intravenous infusion

Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion

infusion rate 1000mg/hr

Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr

All-Cause Mortality
Vancomycin Continous Infusion Intermittent Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vancomycin Continous Infusion Intermittent Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vancomycin Continous Infusion Intermittent Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)   4/22 (18.18%) 
Renal and urinary disorders     
Nephrotoxicity  [1]  1/22 (4.55%)  4/22 (18.18%) 
Indicates events were collected by systematic assessment
[1]
Nephrotoxicity was defined as an increase in serum creatinine (SCr) by 0.5 mg/dL or at least a 50% increase from baseline over 2 consecutive SCr values.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hsin Lin
Organization: Massachusetts General Hospital
Phone: 6177241314
EMail: hlin13@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Hsin Jung Lin, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01786161     History of Changes
Other Study ID Numbers: P 002617
First Submitted: February 4, 2013
First Posted: February 7, 2013
Results First Submitted: March 27, 2017
Results First Posted: May 5, 2017
Last Update Posted: June 7, 2017